Events

Recall of Siemens syngo WorkFlow SLR, Radiological Information System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64737
  • Event Risk Class
    Class 2
  • Event Number
    Z-1105-2013
  • Event Initiated Date
    2012-10-05
  • Event Date Posted
    2013-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116883
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Under certain conditions, when using the search functionality, the potential exists for the wrong patient's interactive documents to display when viewing a signed report in the single patient view. this can occur when the interactive document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. the notes viewer will.
  • Action
    Siemens Medical sent a Customer Safety Advisory Notice letter dated October 5, 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. There will be a Hot Fix available. If you have any further questions please contact Siemens Customer Product Support at (1-888) 767-8326.

Device

Siemens syngo WorkFlow SLR, Radiological Information System
  • Model / Serial
    Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.
  • Product Description
    Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 || The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA